7 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code JJH·June 5, 2019
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
FDA Recall
Terminated
·NeuMoDx Molecular Inc·Product code QJR·May 4, 2021
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code OOI·January 28, 2020
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code OWG·April 8, 2020
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code QLT·November 8, 2021
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code QLT·July 15, 2020
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018